The U.S. Food and Drug Administration (FDA) recently called for testosterone drug manufacturers to collaborate on new testosterone drug safety clinical trials.

These studies are designed to show whether or not side effects of low testosterone drugs can increase a person’s risk of heart problems. The studies will also show whether or not the medications actually provide any benefits for men whose drops in testosterone levels can be attributed to age.

FDA officials asked the testosterone manufacturers to satisfactorily prove that their testosterone drugs help men who do not have “classic hypogonadism” without detrimental increases in risk of medical complications such as heart attacks and strokes.

The FDA is concerned that middle-aged and/or elderly men who take testosterone drugs may not benefit from these medications, and could be placed at risk for medical complications.

Some people are currently pursuing lawsuits against testosterone drug manufacturers over concerns that the companies are engaging in aggressive marketing tactics despite alleged severe side effects like testosterone heart attacks.

According to these lawsuits, some doctors are even providing testosterone drugs without any knowledge of their patients’ testosterone levels. This suggests that some patients taking low testosterone drugs may not have low testosterone levels at all.

The FDA found in recent testosterone drug research that at least 28 percent of men who were prescribed low testosterone drugs had probably not been tested for testosterone levels.

Testosterone Drug Studies and Safety Issues

A 2013 study published in the Journal of the American Medical Association (JAMA) showed that older men who begin taking testosterone drugs after coronary angiography were at a higher risk of suffering from serious cardiovascular events, including heart attacks, stroke, or death.

A 2014 study found that the serious side effects associated with testosterone drugs may double the risk of heart attacks in men 65 years of age or older. The study also showed that, for younger men with a prior history of heart disease, testosterone drugs could double the risk of heart attacks.

A 2015 study found that those who use testosterone for the first time may be about 40 percent more likely to have a heart attack compared to men who do not use the drugs.

In response to these testosterone studies, the FDA announced that testosterone therapy would include a warning label update. This update would include information about the potential link between testosterone drugs and serious heart problems. The FDA also indicated that testosterone therapy should only be used by men actually diagnosed with hypogonadism.

Testosterone Drug Lawsuits

Testosterone drug manufacturers are facing a growing number of lawsuits, including but not limited to Androgel lawsuits, Axiron lawsuits, and Testim lawsuits.

Injured parties file these testosterone drug lawsuits, alleging that the manufacturers neglected to adequately warn the medical community and consumers about the potential risk of serious cardiovascular events associated with their products.

Thousands of men and their families in the United States have filed these kinds of testosterone drug lawsuits. These men may have suffered a sudden heart attack, deep vein thrombosis (DVT), stroke, or death while or after using testosterone drugs.

Plaintiffs claim that, had these drug companies adequately and accurately warned the public about their products’ risks, these medical complications would not have occurred.

Testosterone drug litigation has been centralized as part of a multidistrict litigation, and a few bellwether Androgel cases are being prepared to kick off the trials.